MAT2203

MAT2203 is an investigational oral formulation of amphotericin B utilizing Matinas BioPharma’s proprietary lipid nanocrystal (LNC) drug delivery technology. Amphotericin B is a broad-spectrum fungicidal agent traditionally available only as intravenous formulations due to its poor oral bioavailability and significant toxicity risks, especially nephrotoxicity. MAT2203 encapsulates amphotericin B within a multilamellar spiral crystalline LNC structure composed of phosphatidylserine stabilized by calcium ions. This design enables oral administration by protecting the drug from gastric degradation and facilitating targeted delivery to infected tissues via phagocyte-mediated uptake. Once inside infected cells, the lower intracellular calcium concentration disrupts the LNC structure, releasing active amphotericin B at the site of infection while maintaining low serum concentrations and reducing systemic toxicity. MAT2203 has demonstrated efficacy in Phase 2 trials for cryptococcal meningitis (notably in HIV patients), meeting primary endpoints with robust survival rates and favorable safety profiles compared to IV-administered formulations. It is also being developed for other invasive fungal infections such as aspergillosis, candidiasis (including Candida auris), mucormycosis, and certain endemic mycoses—particularly in patients who cannot tolerate or are resistant to azoles or echinocandins. The FDA has granted Orphan Drug designation for cryptococcosis as well as Fast Track and Qualified Infectious Disease Product designations for candidiasis and aspergillosis[8]. As of May 2025, MAT2203 is not yet approved anywhere globally but has completed Phase 2 studies in cryptococcal meningitis and is preparing for a pivotal Phase 3 trial in invasive aspergillosis[1][5][9].

Brand names

Bioral Amphotericin B

Other names

encochleated amphotericin Boral lipid nanocrystal amphotericin B